Everolimus-eluting versus sirolimus-eluting stents in patients undergoing percutaneous coronary intervention

The excellent (efficacy of Xience/Promus versus cypher to reduce late loss after stenting) randomized trial

Kyung Woo Park, In Ho Chae, Do-Sun Lim, Kyoo Rok Han, Han Mo Yang, Hae Young Lee, Hyun Jae Kang, Bon Kwon Koo, Taehoon Ahn, Jung Han Yoon, Myung Ho Jeong, Taek Jong Hong, Woo Young Chung, Sang Ho Jo, Young Jin Choi, Seung Ho Hur, Hyuck Moon Kwon, Dong Woon Jeon, Byung Ok Kim, Si Hoon Park & 5 others Nam Ho Lee, Hui Kyung Jeon, Hyeon Cheol Gwon, Yang Soo Jang, Hyo Soo Kim

Research output: Contribution to journalArticle

102 Citations (Scopus)

Abstract

Objectives: The goal of this study was to compare the angiographic outcomes of everolimus-eluting stents (EES) and sirolimus-eluting stents (SES) in a head-to-head manner. Background: EES have been shown to be superior to paclitaxel-eluting stents in inhibiting late loss (LL) and clinical outcome. Whether EES may provide similar angiographic and clinical outcomes compared with SES is undetermined. Methods: This was a prospective, randomized, open-label, multicenter trial to demonstrate the noninferiority of EES compared with SES in preventing LL at 9 months. A total of 1,443 patients undergoing percutaneous coronary intervention were randomized 3:1 to receive EES or SES. Routine follow-up angiography was recommended at 9 months. The primary endpoint was in-segment LL at 9 months, and major secondary endpoints included in-stent LL at 9 months, target lesion failure, cardiac death, nonfatal myocardial infarction, target lesion revascularization, and stent thrombosis at 12 months. Data were managed by an independent management center, and clinical events were adjudicated by an independent adjudication committee. Results: Clinical follow-up was available in 1,428 patients and angiographic follow-up in 924 patients (1,215 lesions). The primary endpoint of the study (in-segment LL at 9 months) was 0.11 ± 0.38 mm and 0.06 ± 0.36 mm for EES and SES, respectively (p for noninferiority = 0.0382). The in-stent LL was also noninferior (EES 0.19 ± 0.35 mm; SES 0.15 ± 0.34 mm; p for noninferiority = 0.0121). The incidence of clinical endpoints was not statistically different between the 2 groups, including target lesion failure (3.75% vs. 3.05%; p = 0.53) and stent thrombosis (0.37% vs. 0.83%; p = 0.38). Conclusions: EES were noninferior to SES in inhibition of LL after stenting, which was corroborated by similar rates of clinical outcomes. (Efficacy of Xience/Promus Versus Cypher in Reducing Late Loss After Stenting [EXCELLENT]; NCT00698607)

Original languageEnglish
Pages (from-to)1844-1854
Number of pages11
JournalJournal of the American College of Cardiology
Volume58
Issue number18
DOIs
Publication statusPublished - 2011 Oct 25

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Sirolimus
Percutaneous Coronary Intervention
Stents
Everolimus
Thrombosis

Keywords

  • everolimus
  • percutaneous coronary intervention
  • sirolimus
  • stents

ASJC Scopus subject areas

  • Cardiology and Cardiovascular Medicine

Cite this

Everolimus-eluting versus sirolimus-eluting stents in patients undergoing percutaneous coronary intervention : The excellent (efficacy of Xience/Promus versus cypher to reduce late loss after stenting) randomized trial. / Park, Kyung Woo; Chae, In Ho; Lim, Do-Sun; Han, Kyoo Rok; Yang, Han Mo; Lee, Hae Young; Kang, Hyun Jae; Koo, Bon Kwon; Ahn, Taehoon; Yoon, Jung Han; Jeong, Myung Ho; Hong, Taek Jong; Chung, Woo Young; Jo, Sang Ho; Choi, Young Jin; Hur, Seung Ho; Kwon, Hyuck Moon; Jeon, Dong Woon; Kim, Byung Ok; Park, Si Hoon; Lee, Nam Ho; Jeon, Hui Kyung; Gwon, Hyeon Cheol; Jang, Yang Soo; Kim, Hyo Soo.

In: Journal of the American College of Cardiology, Vol. 58, No. 18, 25.10.2011, p. 1844-1854.

Research output: Contribution to journalArticle

Park, KW, Chae, IH, Lim, D-S, Han, KR, Yang, HM, Lee, HY, Kang, HJ, Koo, BK, Ahn, T, Yoon, JH, Jeong, MH, Hong, TJ, Chung, WY, Jo, SH, Choi, YJ, Hur, SH, Kwon, HM, Jeon, DW, Kim, BO, Park, SH, Lee, NH, Jeon, HK, Gwon, HC, Jang, YS & Kim, HS 2011, 'Everolimus-eluting versus sirolimus-eluting stents in patients undergoing percutaneous coronary intervention: The excellent (efficacy of Xience/Promus versus cypher to reduce late loss after stenting) randomized trial', Journal of the American College of Cardiology, vol. 58, no. 18, pp. 1844-1854. https://doi.org/10.1016/j.jacc.2011.07.031
Park, Kyung Woo ; Chae, In Ho ; Lim, Do-Sun ; Han, Kyoo Rok ; Yang, Han Mo ; Lee, Hae Young ; Kang, Hyun Jae ; Koo, Bon Kwon ; Ahn, Taehoon ; Yoon, Jung Han ; Jeong, Myung Ho ; Hong, Taek Jong ; Chung, Woo Young ; Jo, Sang Ho ; Choi, Young Jin ; Hur, Seung Ho ; Kwon, Hyuck Moon ; Jeon, Dong Woon ; Kim, Byung Ok ; Park, Si Hoon ; Lee, Nam Ho ; Jeon, Hui Kyung ; Gwon, Hyeon Cheol ; Jang, Yang Soo ; Kim, Hyo Soo. / Everolimus-eluting versus sirolimus-eluting stents in patients undergoing percutaneous coronary intervention : The excellent (efficacy of Xience/Promus versus cypher to reduce late loss after stenting) randomized trial. In: Journal of the American College of Cardiology. 2011 ; Vol. 58, No. 18. pp. 1844-1854.
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abstract = "Objectives: The goal of this study was to compare the angiographic outcomes of everolimus-eluting stents (EES) and sirolimus-eluting stents (SES) in a head-to-head manner. Background: EES have been shown to be superior to paclitaxel-eluting stents in inhibiting late loss (LL) and clinical outcome. Whether EES may provide similar angiographic and clinical outcomes compared with SES is undetermined. Methods: This was a prospective, randomized, open-label, multicenter trial to demonstrate the noninferiority of EES compared with SES in preventing LL at 9 months. A total of 1,443 patients undergoing percutaneous coronary intervention were randomized 3:1 to receive EES or SES. Routine follow-up angiography was recommended at 9 months. The primary endpoint was in-segment LL at 9 months, and major secondary endpoints included in-stent LL at 9 months, target lesion failure, cardiac death, nonfatal myocardial infarction, target lesion revascularization, and stent thrombosis at 12 months. Data were managed by an independent management center, and clinical events were adjudicated by an independent adjudication committee. Results: Clinical follow-up was available in 1,428 patients and angiographic follow-up in 924 patients (1,215 lesions). The primary endpoint of the study (in-segment LL at 9 months) was 0.11 ± 0.38 mm and 0.06 ± 0.36 mm for EES and SES, respectively (p for noninferiority = 0.0382). The in-stent LL was also noninferior (EES 0.19 ± 0.35 mm; SES 0.15 ± 0.34 mm; p for noninferiority = 0.0121). The incidence of clinical endpoints was not statistically different between the 2 groups, including target lesion failure (3.75{\%} vs. 3.05{\%}; p = 0.53) and stent thrombosis (0.37{\%} vs. 0.83{\%}; p = 0.38). Conclusions: EES were noninferior to SES in inhibition of LL after stenting, which was corroborated by similar rates of clinical outcomes. (Efficacy of Xience/Promus Versus Cypher in Reducing Late Loss After Stenting [EXCELLENT]; NCT00698607)",
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TY - JOUR

T1 - Everolimus-eluting versus sirolimus-eluting stents in patients undergoing percutaneous coronary intervention

T2 - The excellent (efficacy of Xience/Promus versus cypher to reduce late loss after stenting) randomized trial

AU - Park, Kyung Woo

AU - Chae, In Ho

AU - Lim, Do-Sun

AU - Han, Kyoo Rok

AU - Yang, Han Mo

AU - Lee, Hae Young

AU - Kang, Hyun Jae

AU - Koo, Bon Kwon

AU - Ahn, Taehoon

AU - Yoon, Jung Han

AU - Jeong, Myung Ho

AU - Hong, Taek Jong

AU - Chung, Woo Young

AU - Jo, Sang Ho

AU - Choi, Young Jin

AU - Hur, Seung Ho

AU - Kwon, Hyuck Moon

AU - Jeon, Dong Woon

AU - Kim, Byung Ok

AU - Park, Si Hoon

AU - Lee, Nam Ho

AU - Jeon, Hui Kyung

AU - Gwon, Hyeon Cheol

AU - Jang, Yang Soo

AU - Kim, Hyo Soo

PY - 2011/10/25

Y1 - 2011/10/25

N2 - Objectives: The goal of this study was to compare the angiographic outcomes of everolimus-eluting stents (EES) and sirolimus-eluting stents (SES) in a head-to-head manner. Background: EES have been shown to be superior to paclitaxel-eluting stents in inhibiting late loss (LL) and clinical outcome. Whether EES may provide similar angiographic and clinical outcomes compared with SES is undetermined. Methods: This was a prospective, randomized, open-label, multicenter trial to demonstrate the noninferiority of EES compared with SES in preventing LL at 9 months. A total of 1,443 patients undergoing percutaneous coronary intervention were randomized 3:1 to receive EES or SES. Routine follow-up angiography was recommended at 9 months. The primary endpoint was in-segment LL at 9 months, and major secondary endpoints included in-stent LL at 9 months, target lesion failure, cardiac death, nonfatal myocardial infarction, target lesion revascularization, and stent thrombosis at 12 months. Data were managed by an independent management center, and clinical events were adjudicated by an independent adjudication committee. Results: Clinical follow-up was available in 1,428 patients and angiographic follow-up in 924 patients (1,215 lesions). The primary endpoint of the study (in-segment LL at 9 months) was 0.11 ± 0.38 mm and 0.06 ± 0.36 mm for EES and SES, respectively (p for noninferiority = 0.0382). The in-stent LL was also noninferior (EES 0.19 ± 0.35 mm; SES 0.15 ± 0.34 mm; p for noninferiority = 0.0121). The incidence of clinical endpoints was not statistically different between the 2 groups, including target lesion failure (3.75% vs. 3.05%; p = 0.53) and stent thrombosis (0.37% vs. 0.83%; p = 0.38). Conclusions: EES were noninferior to SES in inhibition of LL after stenting, which was corroborated by similar rates of clinical outcomes. (Efficacy of Xience/Promus Versus Cypher in Reducing Late Loss After Stenting [EXCELLENT]; NCT00698607)

AB - Objectives: The goal of this study was to compare the angiographic outcomes of everolimus-eluting stents (EES) and sirolimus-eluting stents (SES) in a head-to-head manner. Background: EES have been shown to be superior to paclitaxel-eluting stents in inhibiting late loss (LL) and clinical outcome. Whether EES may provide similar angiographic and clinical outcomes compared with SES is undetermined. Methods: This was a prospective, randomized, open-label, multicenter trial to demonstrate the noninferiority of EES compared with SES in preventing LL at 9 months. A total of 1,443 patients undergoing percutaneous coronary intervention were randomized 3:1 to receive EES or SES. Routine follow-up angiography was recommended at 9 months. The primary endpoint was in-segment LL at 9 months, and major secondary endpoints included in-stent LL at 9 months, target lesion failure, cardiac death, nonfatal myocardial infarction, target lesion revascularization, and stent thrombosis at 12 months. Data were managed by an independent management center, and clinical events were adjudicated by an independent adjudication committee. Results: Clinical follow-up was available in 1,428 patients and angiographic follow-up in 924 patients (1,215 lesions). The primary endpoint of the study (in-segment LL at 9 months) was 0.11 ± 0.38 mm and 0.06 ± 0.36 mm for EES and SES, respectively (p for noninferiority = 0.0382). The in-stent LL was also noninferior (EES 0.19 ± 0.35 mm; SES 0.15 ± 0.34 mm; p for noninferiority = 0.0121). The incidence of clinical endpoints was not statistically different between the 2 groups, including target lesion failure (3.75% vs. 3.05%; p = 0.53) and stent thrombosis (0.37% vs. 0.83%; p = 0.38). Conclusions: EES were noninferior to SES in inhibition of LL after stenting, which was corroborated by similar rates of clinical outcomes. (Efficacy of Xience/Promus Versus Cypher in Reducing Late Loss After Stenting [EXCELLENT]; NCT00698607)

KW - everolimus

KW - percutaneous coronary intervention

KW - sirolimus

KW - stents

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